We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug News
    • Trending
    • Commercial Operations
    • GMPs
    • FDA Enforcement Actions
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Drug Weekly
    • FDAnews
  • Device News
    • Trending
    • Commercial Operations
    • FDA Enforcement Actions
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Device Weekly
    • FDAnews
  • Books
    • FDAnews Books Library
    • Drug Books
    • Device Books
  • Training/Events
    • Webinar Training Pass
    • Events
  • Resources
    • Form 483s Database
    • FDA Approved Drugs
    • eCFR and Guidances
    • White Papers
  • CenterWatch
  • About Us
    • The Company
    • FDAnews Editorial Board
    • Contact Us
  • Advertising
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Store » Webinar Recordings » REMS: Requirements, Regulation, and Enforcement - Webinar Recording/Transcript

Other Options

Audio Recording/Transcript - Nov. 28, 2018

$287.00

Audio Recording/Transcript - Nov. 28, 2018

$258.00

Audio Recording/Transcript - Nov. 28, 2018

$244.00

Audio Recording/Transcript - Nov. 28, 2018

$230.00

Audio Recording/Transcript - Nov. 28, 2018

$215.00

REMS: Requirements, Regulation, and Enforcement - Webinar Recording/Transcript

$287.00
Webinar Recordings

Product Details

REMS: Requirements, Regulation, and Enforcement — Evolution from Safety Program to Enforcement Tool

REMS has evolved into a powerful enforcement tool.

Last year there were to significant settlements involving a manufacturer’s failure to comply with REMS strategies.

The Novo Nordisk settlement resulted in disgorgement of $12 million and a payment of $46.5 mill to resolve the False Claims Act liability.

The settlement by Aegerion contained both criminal and civil components. On the criminal side, the company admitted two misdemeanor violations of the FD&C Act, and agreed to pay $7.2 million in criminal fines and forfeiture. The company also entered into a Deferred Prosecution Agreement with the government to resolve charges of conspiracy to violate HIPAA. The civil settlement included a $28.8 million payment for False Claims Act violations, a Corporate Integrity Agreement, and a Consent Decree of permanent injunction.

FDAnews has called on Anne K. Walsh, a Washington, D.C., attorney to discuss why the REMS evolution has occurred and how to prepare for future changes. Her presentation alerts you to likely regulatory and legislative changes ahead in coming months, and positions you for better compliance. You’ll learn about:

  • The recently changed requirements evolving REMS from a safety initiative to a powerful enforcement tool
  • How to protect your company from enforcement actions and strategies for defending an enforcement
  • The most successful strategies to defend against a False Claims Act case based on compliance with safety requirements
  • Recent settlements and what they mean
  • How to prevent a Deferred Prosecution Agreement with the government to resolve charges of conspiracy to violate HIPAA

Failure to prepare for REMS changes could result in penalties — civil, and even criminal ones. Don’t take that risk.

  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell or Share My Data
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing